Kornimate/medical-research-clean huggingface dataset:
non-invasive brain stimulation and substance use

Conditions: Substance Use Disorders

Summary: the will investigate the feasibility and effectiveness and initial efficacy of non-invasive transcranial alternating current stimulation (tacs) on distress tolerance and inhibitory control among treatment seeking substance users.

disruptions in inhibitory control (ic) and distress tolerance (dt) are implicated in the development and maintenance of substance use disorders. findings suggest that differential dlpfc engagement during affective and cognitive processing, and in particular, distress tolerance, in substance use disorder may be malleable, providing a promising intervention. modulating neural oscillations with non-invasive, safe brain stimulation by targeting regions such as the dlpfc may provide an avenue to improve distress tolerance and inhibitory control in sud. transcranial alternating current stimulation (tacs) may be a particularly promising approach as it is a safe and non-invasive method of electric stimulation that has the potential to effectively modulate neural network and circuit dynamics, more closely aligning with a network-based conceptualization of affective and cognitive processesthis study will test the effects of tacs on distress tolerance and inhibitory control among treatment-seeking adults with substance use disorder.

Eligibility criteria:
inclusion criteria: * current diagnostic and statistical manual of mental disorders (dsm-v) substance use disorder * current smoker * abstinent from all substances (except nicotine) for at least the past 2 weeks exclusion criteria: * current use of antiepileptic drugs and/or benzodiazepines * less than 6 months since an electroconvulsive therapy (ect) session * current dsm-v psychotic disorder * pregnancy and/or nursing * ongoing or history of traumatic brain injury (tbi), reoccurring seizures, stroke, or brain tumors * medical or neurological illness * brain devices and/or implants

Keywords: tacs brain stimulation transcranial alternating current stimulation substance use
a study to evaluate the efficacy and safety of faricimab in participants with neovascular age-related macular degeneration (tenaya)

Conditions: Wet Macular Degeneration

Summary: this study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (q8w), in participants with neovascular age-related macular degeneration (namd).


Eligibility criteria:
inclusion criteria: * treatment-naïve choroidal neovascularization (cnv) secondary to age-related macular degeneration (namd) in the study eye * ability to comply with the study protocol, in the investigator's judgment * for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment * other protocol-specified inclusion criteria may apply exclusion criteria: * uncontrolled blood pressure, defined as systolic blood pressure \>180 millimeters of mercury (mmhg) and/or diastolic blood pressure \>100 mmhg while a patient is at rest on day 1 * pregnancy or breastfeeding, or intention to become pregnant during the study * cnv due to causes other than amd in the study eye * any history of macular pathology unrelated to amd affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye * any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study * uncontrolled glaucoma in the study eye * any prior or concomitant treatment for cnv or vitreomacular-interface abnormalities in the study eye * prior ivt administration of faricimab in either eye * history of idiopathic or autoimmune-associated uveitis in either eye * active ocular inflammation or suspected or active ocular or periocular infection in either eye * other protocol-specified exclusion criteria may apply

Keywords: amd namd neovascular age-related macular degeneration choroidal neovascularization secondary to age-related macular degeneration
tolerability of hypertonic saline in infants with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the objective of the study is to determine whether or not inhalation of hypertonic saline will be tolerated by infants with cystic fibrosis and the effect of inhalation on their lung function.

cystic fibrosis lung disease is characterized by mucous retention which favors secondary bacterial infection and inflammation, which leads to lung damage and ultimately respiratory failure. classically, therapeutic interventions are aimed to improve mucociliary clearance, to reduce both bacterial load and lower airway inflammation. hypertonic saline (hs) has been used for the induction of sputum production in all age groups to obtain secretions from the lower respiratory for diagnostic purposes. hypertonic saline is also used in older children with cf, who do not produce sputum spontaneously, to obtain representative samples for microbiology. there is evidence from studies in patients with cystic fibrosis that hs can improve mucociliary clearance. the improvement was more impressive in areas that were well ventilated, making it likely that hs will work better in patients with relatively preserved pulmonary function. newer evidence also suggests that the osmotic effect on the airway surface that was expected to be short lived, may actually persist for longer time periods (up to 8 hours). all these data indicate that hs may be a useful agent in the treatment of cf patients. as the effect on mucociliary clearance was found to be better in areas with adequate ventilation, it is logical to assume that treatment with hs may be most efficacious when initiated early in the disease process. so far, no data on the tolerability of inhalation of hs are available for infants with cystic fibrosis. however, evidence from infants with aids as well as recent studies in infants with bronchiolitis suggest that hypertonic saline can be safely administered by inhalation in infants. nevertheless, proof of tolerability in cf infants is a prerequisite for longer term studies of hs in this age group. in older children, tolerability has been tested by measuring pulmonary function both before and after inhalation of hs saline. similar data are not yet available for infants.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cystic fibrosis * age 2 months to 2 years * routinely scheduled infant pulmonary function test. * clinical stability (no respirator tract infection for 4 weeks prior to study exclusion criteria: * acute respiratory symptoms * wheezing at the time of study * supplemental oxygen therapy * oxygen saturation \< 95 % on room air

Keywords: cystic fibrosis hypertonic saline infants
hypofractionated imrt (vmat-ra) for elderly patients with newly diagnosed high grade glioma

Conditions: Glioma

Summary: to assess the effect of imrt using vmat rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed hgg.

investigators designed this study with the aim to assess the effect of imrt using vmat rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed hgg. the potential advantage of this approach is deliver a more selective irradiation to tumor's target with reducing the dose to normal brain and to allow the delivery of a higher dose, optimizing the therapeutic window.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 70 years * karnosky performance status (kps) ≤60 * histologically confirmed hgg after tumor biopsy * gbm * anaplastic astrocytoma * anaplastic oligoastrocytoma * anaplastic oligodendroglioma without idh1 mutation and no codeletion 1p19q * estimated survival ≥ 3 months. * normal liver, kidney and bone marrow function * written informed consent exclusion criteria: * prior radiation therapy * other primary cancer exclusion criteria: -

Keywords: hgg
effect of goji berry consumption on biochemical parameters

Conditions: Healthy; Hyperlipidemias

Summary: goji berry as a functional food have been shown to reduce risk of hyperlipidemia, type 2 diabetes, etc. however, human studies are limited in this area. in this study, it has been aimed to evaluate the effect of goji berry consumption on some biochemical parameters in healthy individuals.

healthy individuals have been divided into control and study groups. individuals in both group have same characteristics such as age, gender, and body mass index (control group: 35 individuals - study group: 35 individuals). both group were asked to maintain their normal diets. in addition, the study group consume 20 g of dried goji berry per day and did not consume any fruit with a similar antioxidant content during the 8 weeks study period. the control group was asked to exclude goji berry and similar fruits with high antioxidant content from their diet during the 8 weeks study period. the 20 g goji berry for per day was given weekly to each individual in a study group in transparent bags. at the beginning of the study and every 15 days, food consumption record for 3 consecutive days (2 weekdays and 1 weekend), a 3-day physical activity record, and anthropometric measurements (weight, height, waist and hip circumferences, body composition analysis) were taken. blood parameters (total cholesterol, high density lipoprotein (hdl), low density lipoprotein (ldl), very low density lipoprotein (vldl), triglyceride, glucose, insulin, homeostatic model assessment of insulin resistance (homa-ir), hba1c) of individuals were taken at the beginning and the end of the study.

Eligibility criteria:
inclusion criteria: * bmi between 20-25 kg/m² * female individuals are not in the period of lactation and menopause, * absence of any chronic or acute disease diagnosed by a physician, * no allergies to goji berry * not consuming goji berry and similar fruits regularly for the last 1 month. * not being in the process of body weight loss * not doing strenuous physical activity * not taking any medication or antioxidant vitamin support * not smoking * not consuming alcohol (moderate alcohol consumption) exclusion criteria: not meeting the criteria for inclusion in the study

Keywords: functional food goji berry serum lipids serum fasting glucose
chiglitazar/metformin in non-obese women with pcos

Conditions: Polycystic Ovary Syndrome; Chiglitazar; Metformin

Summary: polycystic ovary syndrome (pcos) is the most common endocrine and metabolic disorders in women of reproductive age, and its prevalence rate is from 9% (nih criteria) to 18% (rotterdamcriteria). it is clinically characterized by hyperandrogenism, persistent anovulation, and polycystic ovarian changes. moreover it is often accompanied by insulin resistance and obesity. now, metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome. chiglitazar is a novel peroxisome proliferation activated receptor (ppar) agonist. treatment of type 2 diabetes mellitus by moderate activation of pparα, pparγ and pparδ, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization. however, there is limited evidence for its treatment of insulin resistance in women with pcos. therefore, investigators applied chiglitazar and metformin to two groups of pcos patients to understand their effects on insulin resistance.


Eligibility criteria:
inclusion criteria: 1. female aged 18- 45 years old 2. normal weight bmi 18.5--24 3. diagnosis of hyperandrogenism t\>0.481ng/ml 4. the diagnosis of pcos is based on the diagnostic criteria established by the rotterdam consensus 5. no use of drugs affecting reproductive endocrine in the 3 months prior to the clinic visit exclusion criteria: 1. t level is within the normal range 2. organ dysfunction 3. drugs that can affect endocrine such as contraceptives and steroids taken in the past 3 months 4. confirmed diagnosis of diabetes 5. are on a diet, use weight-affecting medications, or have experienced a weight change of \>4.5kg within 3 months prior to the start of the study 6. have other endocrine disorders, such as thyroid dysfunction, adrenal gland disease, hyperprolactinemia, etc. 7. combined psychiatric disorders and severe primary diseases 8. allergy to the drug or components of this study 9. those who do not follow the doctor's instructions during the medication, or discontinue the treatment due to serious adverse reactions
therapeutic touch on labour pain, anxiety and childbirth attitude

Conditions: First Pregnancy; Vaginal Delivery

Summary: introduction: touching ensures physical, emotional and spiritual relaxation, confidence, peace, calmness and well-being, and increases self-esteem. the aim of this study is to determine the effect of therapeutic touch on labour pain, anxiety and childbirth attitude. methods: the sample of this randomized controlled experimental research consisted of 80 (intervention group: 40; control group: 40) women. data were collected using a personal information form, visual analogue scale, state anxiety inventory and childbirth attitudes questionnaire.


Eligibility criteria:
inclusion criteria: * having a first pregnancy * not having a high-risk pregnancy * having no health problems with the baby or herself * having a single foetus * being about to have a vaginal delivery * not receiving infertility treatment * not having a chronic physical or psychiatric diagnosis * agreeing to participate in the research exclusion criterion -multiparity

Keywords: therapeutic touch labour pain anxiety childbirth attitude
a research study looking at the safety of multiple doses of zp8396 and how it works in the body of healthy participants

Conditions: Overweight; Healthy Volunteers; Obese

Summary: the trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial in normal weight and overweight but otherwise healthy subjects randomised to subcutaneous administration of zp8396 or placebo

the research study will investigate the safety and tolerability of zp8396 in healthy study participants. in addition, the study will investigate how zp8396 works in the body (pharmacokinetics and pharmacodynamics). the trial is divided in two parts: part 1: 20 participants will receive 6 once-weekly doses as an injection under the skin (subcutaneous, s.c.). participants will have 14 visits with the study team. 6 of these visits consists of overnight stays of different duration (2-4 nights) at the study site. for each participant, the study will last up to 116 days. part 2: 48 participants will receive 16 once-weekly doses as an injection under the skin (subcutaneous, s.c.) in a dose up-titration dose scheme. participants will have 23 or 24 visits with the study team. 13 of these visits consists of overnight stays of different duration (2-4 nights) at the study site. for each participant, the study will last up to 198 days.

Eligibility criteria:
inclusion criteria: part 1: * body mass index (bmi) between 21.0 and 29.9 kg/m\^2, both inclusive * glycosylated hemoglobin (hba1c) below 5.7 percent further inclusion criteria apply part 2: * body mass index (bmi) between 27.0 and 39.9 kg/m\^2, both inclusive * glycosylated hemoglobin (hba1c) below 6.5 percent further inclusion criteria apply exclusion criteria: part 1: * history of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke * systolic blood pressure below 90 mmhg or above 139 mmhg and/or diastolic blood pressure below 50 mmhg or above 89 mmhg * symptoms of arterial hypotension further exclusion criteria apply part 2: * history of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke * systolic blood pressure below 90 mmhg or above 159 mmhg and/or diastolic blood pressure below 50 mmhg or above 99 mmhg * symptoms of arterial hypotension further exclusion criteria apply
prospective study of active pain management in lung cancer outpatients (apm)

Conditions: Lung Cancer

Summary: this study is: * a single-center, randomized, prospective controlled trial. * to prove superiority of active pain management group compared to control group by the percent of pain intensity difference of outpatients with lung cancer pain. * 204 patients will be recruited.

* the recruited patients in both group will be provided the education about pain-killer, and received medicines including opioids according to their numeric rating scale (nrs) * active management group will be provided additional telephone counseling and dosage modification by specialized nurse for cancer pain. * the percent of pain intensity difference (%pid) * pid = (nrs of visit 1 - nrs of visit 3)/nrs of visit 1

Eligibility criteria:
inclusion criteria: * outpatients with lung cancer. * the patients with uncontrolled lung cancer pain - more than and equal nrs 4 pain during previous 24 hours for background pain, or more than and equal 3 times/day for breakthrough painkiller medication. * over 20 year-old male or female. * the patients can be able to received telephone counseling by investigator's decision. exclusion criteria: * drug or alcohol abusers. * child-bearing women or pregnant women. * the patients with moderate to severe psychiatric problems. * the patients who have hypersensitivity to opioids.

Keywords: lung cancer cancer pain opioid
long-term, safety, tolerability and efficacy study of afq056 in adult patients with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: the purpose of this study is to generate long-term safety, tolerability and efficacy data for afq056 in eligible adult patients with fxs who have participated in the cafq056a2212 (nct01253629).study and patients who have participated in the previous proof-of-concept study cafq056a2204 (nct00718341).

a 148 patients were enrolled into this treatment extension trial conducted for at least 3 years. this extension trial was terminated after the decision to terminate the afq056 development program. the decision was based on the results of two randomized, double blind, placebo controlled phase iib trials in adult and adolescent fxs patients (cafq056a2212 and cafq056b2214respectivly), both of which failed to demonstrate efficacy in the fxs population. as this extension trial was terminated, only the primary objective and safety are represented.

Eligibility criteria:
inclusion criteria group 1 patients * had to have completed the cafq056a2212 study or another study of afq056 which included adult fxs patients within one week of enrollment into the open-label study. * females of child-bearing potential had to follow protocol requirements with respect to contraception. * have a caregiver or caregivers who spent, on average, at least six hours per day with the patient, who were willing and capable of supervising treatment, providing input into efficacy and safety assessments, and accompanying the patient to study visits. group 2: * had to have: * completed study cafq056a2204. * completed study cafq056a2212 or another study of afq056 which included adult patients with fxs but enrollment into the current study was delayed for more than a week. * discontinued prematurely from study cafq056a2212 or another study of afq056 which included adult patients with fxs due to intolerability of the dosage in the patient's assigned treatment group. * females of child-bearing potential had to follow protocol requirements with respect to contraception. * have a caregiver or caregivers who spent, on average, at least six hours per day with the patient, who were willing and capable of supervising treatment, providing input into efficacy and safety assessments, and accompanying the patient to study visits exclusion criteria any advanced, severe or unstable disease * history of severe self- injurious behavior * history of uncontrolled seizure disorder or resistant to therapy within the past 2 years (patients who are clinically stable under anti-convulsant therapy for the past 2 years are not excluded) * history of clinically significant allergies requiring hospitalization or non- inhaled corticosteroid therapy (asthma, anaphylaxis, etc.) * using (or used within 6 weeks before baseline) concomitant medications that are potent inhibitors or inducers of cyp3a4 * using glutamatergic agents (riluzole, memantine, etc.) or lithium, digoxin, or warfarin within 6 weeks of baseline other protocol-defined inclusion/exclusion criteria may apply

Keywords: fragile x syndrome martin-bell syndrome genetic diseases x-linked escalante's syndrome
safety and immunogenicity of plant-derived pfs25 vlp-fhcmb malaria transmission blocking vaccine in healthy adults

Conditions: Malaria

Summary: this study is a phase 1, dose escalation, first-in-human study designed primarily to evaluate the safety of the purified plant-derived pfs25 vlp combined with alhydrogel adjuvant


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female aged 18 - 50 years inclusive * able to give written informed consent obtained prior to screening * healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline * women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose. * females should fulfill one of the following criteria: 1. at least one year post-menopausal 2. surgically sterile 3. willing to use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and then for the study duration 4. willing to abstain from sexual intercourse or use another reliable form of contraception approved by the investigator (e.g., intrauterine device (iud), female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) for 30 days prior to first vaccination through 9 months after third vaccination * comprehension of the study requirements, as demonstrated by achieving a score of at least 80% correct on a short multiple-choice quiz. * individuals who fail to achieve a passing score on the initial comprehension assessment will be given the opportunity to retest after a review of protocol information. * individuals who fail the comprehension assessment for the second time will not be enrolled. * available and able to participate in all planned study visits and procedures. exclusion criteria: * history of malaria or previous receipt of an investigational malaria vaccine
nitroglycerin versus terbutaline for intrapartum fetal resuscitation

Conditions: Fetal Distress

Summary: to compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation


Eligibility criteria:
inclusion criteria:: * nonreassuring fetal heart rate tracing exclusion criteria:- maternal cardiac disease, placental abruption, intrauterine growth restriction, prior cesarean section